The Department of Justice (DOJ) and HHS issued a joint letter to state Medicaid administrators urging them to act in accordance with the Americans with Disabilities Act (ADA) and allow…
The Biden administration and Danco Laboratories, manufacturer of the abortion pill mifepristone, have filed briefs petitioning the Supreme Court to keep wider patient access because restricting the drug would have…
An Illinois law that targets “price gouging” for generic drugs is the target of a lawsuit filed by the trade group representing America’s generics and biosimilar manufacturers who claim the…
The Canadian government is not happy with the FDA’s decision to allow the state of Florida to import certain Canadian prescription drugs in bulk, and neither is the powerful U.S.…
Two significant changes in the FDA’s final guidance on updating ANDA labeling are details on how to obtain information on changes to reference listed drug (RLD) labeling and how to…
Novo Nordisk, seeking to remain in the front of the weight loss drug race, has inked a deal with EraCal Therapeutics, a biotech startup, whose small molecule program offers a…
In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply…
Less than two months after its announced investigation of secondary T-cell cancers in patients who received chimeric antigen receptor (CAR)-T cell immunotherapy cancer treatments, the FDA is mandating label updates…
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new…
Sanofi and Inhibrx, a clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates, today announced a $2 billion agreement for Sanofi to acquire Inhibrx. Source: Drug…